J. Douglas Bremner See book keywords and concepts |
I recommend taking a statin that you can buy in generic form, like atorvastatin (generic lipitor), since it costs much less. |
| Statin drugs (Zocor, lipitor, Pravachol and others) can slash a woman's heart-attack risk by more than a third—just as they do in men . . . should you be taking one of these medications?"
The answer is probably not. In a study that combined all of the available information on women from the different clinical trials, the authors found no reduction in heart attacks or mortality in women with high cholesterol who did not have a history of heart diseased That means that if you are a woman with high cholesterol and no history of heart disease, you should not take a statin. |
Andreas Moritz See book keywords and concepts |
Prozac is among the biggest money makers of all times, with a 224,973 percent markup. lipitor is one of the most expensive drugs to produce ($5.80), but it sells for $272.37' its markup is 4,696 percent. Some generic drugs were marked up as much as 3,000 percent or more.
CBS's famous Sixty Minutes national TV show (aired 1st April 2007), revealed the biggest ever health scandal, which so far cost the American public nearly $1.5 trillion. |
Frederic Vagnini, M.D. and Barry Fox, Ph.D. See book keywords and concepts |
There are several different statin drugs, including lipitor (atorvastatin), Mevacor (lovastatin), Zocor (simvastatin), and Pravachol (pravastatin). Millions of Americans— especially the elderly—currently take statin drugs, and millions more will soon join them, because the new National Cholesterol Education Program guidelines suggest that they be prescribed even for people with low-normal cholesterol levels. This means that more people will soon be taking these drugs, they'll start them at a younger age, and they'll continue taking them for longer periods of time. |
Jacky Law See book keywords and concepts |
It may have nothing to do with the tens of billions of dollars single drugs such as cholesterol-reducing lipitor earn year in year out. Or the corruptive forces such rewards inevitably set in motion. The fundamental problem with medicines could be as simple as not wanting to think about them that much.
Certainly, it is hard to find any healthcare more essentially disengaged than popping a pill. Medicines are designed to get into the body as seamlessly with 'normal life' as possible. |
Peter Rost See book keywords and concepts |
The government alleged that Warner-Lambert fraudulently avoided paying a portion of the rebates owed to state and federal governments under the national drug Medicaid rebate program for the cholesterol-lowering drug lipitor.
Pfizer was again forced to sign a corporate integrity agreement in 2004, while agreeing to pay $430 million to resolve civil and criminal charges that Warner-Lambert had defrauded Medicaid by engaging in an aggressive and complex scheme to illegally promote Neurontin, a drug indicated for epilepsy, for at least eleven off-label uses. |
Mark Hyman, M.D. See book keywords and concepts |
Even though the lipitor was controlling his cholesterol, it was doing nothing for his insulin resistance. And despite the lipitor, Albert continued to have high levels of triglycerides and dangerously low levels of the so-called good cholesterol, HDL (high-density lipoprotein). And he had sky-high insulin levels, as well as a substantial amount of inflammation in his bloodstream, as measured by his high C-reactive protein level.
As we said, the drugs simply weren't dealing with Albert's original problem, which was insulin resistance. |
Peter Rost See book keywords and concepts |
This was a major factor in Pfizer's take-over of Warner-Lambert, which gave them lipitor, a cholesterol-lowering agent that eventually created sales of $ 11 billion per year.
As I listened to Fred's voicemail, his stern message startled me. He got to the point right away. Pfizer was going to buy Pharmacia. Fred said that Pfizer had made a great offer, which would result in an almost 40 percent premium over Pharmacia's current share price. There was no way Fred or the board of directors could say no to such a premium. |
Donald L. Barlett and James B. Steele See book keywords and concepts |
But adding lipitor can help lower your total cholesterol 29 percent to 45 percent. ... So take the next step—ask your doctor if lipitor is right for you."
On the afternoon soaps, Novartis Pharmaceuticals pushes its Zel-norm for irritable bowel syndrome with constipation. On the evening news at CBS, it's Merck's Fosamax for osteoporosis in postmenopausal women. On the repeat of the Larry King Live show on CNN at 12:30 A.M., it's Plavix. Bristol-Myers Squibb and Sanofi Pharmaceuticals sell Plavix to keep clots from forming and help protect against a heart attack or stroke. |
Jacky Law See book keywords and concepts |
This was illustrated when its high-earning lipitor, marketed in a complicated arrangement with Warner-Lambert, was threatened. Rumour had it that American Home Products was merging with Warner-Lambert. Pfizer wasn't going to let its partner go without a fight. So it significantly trumped the offer with a hostile $70 billion bid at the end of 1999. This was $20 billion more than anything else on the table. |
Kevin Trudeau See book keywords and concepts |
The dangerous side effects of Vioxx, Celebrex, lipitor and Prozac are not the exception, they are the rule. Due to their synthetic nature, most pharmaceutical drugs are toxic to our bodies, causing organ damage and other serious side effects. According to the American Medical Association, one million American suffered disabilities from taking pharmaceutical drugs and more than 100,000 of them die as a result of this every single year.
3. Legislation that protects the expansion of the deadly business with disease. |
Peter Rost See book keywords and concepts |
You would repeat exactly the same mistakes you did with lipitor and Neurontin. The Endocrine Care franchise has a legal exposure to the following: a. Distribution of a misbranded drug into interstate commerce (21 U.S.C., Sec 331, 333, 352). b. Violation of FDCA to distribute human growth hormone for off-label use. c. Fraud and Abuse issues including Anti-kickback statute and False Claims.
Pharmacia has for more than five years been actively promoting Genotropin for off-label usage, mainly for anti-aging purposes. For growth hormone this is a felony. |
Ray Moynihan and Alan Cassels See book keywords and concepts |
Racking up sales of more than $10 billion a year, lipitor is the world's top-selling prescription drug, ever.6 Its manufacturer Pfizer is the world's biggest pharmaceutical company. With head offices in Manhattan, and a market value around $200 billion, Pfizer is one of the largest corporations on earth, thanks in no small part to widespread fears of high cholesterol.
Sales of these drugs have soared in the last decade because the number of people defined as having "high cholesterol" has grown astronomically. |
Greg Critser See book keywords and concepts |
That meant that the company would have to give up a percentage of lipitor profits in exchange. After a long and furious battle with Warner's chairman, who did not want to give up anything in the launch of the company's first new product in a decade, Wild prevailed. The company they picked, Bill Steere's booming Pfizer, was a perfect fit: it had no competing product and it had a huge sales force of aggressive, young detail people. |
| When I arrived, the sales forecast for lipitor was three quarters of a million in annual sales by the fourth year," he recalls. "It was perceived as being difficult to carve out a new niche, as there were so many other statins. I dove into the data and became convinced that it was a much bigger product. We called a meeting and everyone was quite excited. I threw out a thought: This product is good enough for a twenty-five percent share. People fell off their chairs: no way! It was scary to think about being that big. |
| As Wild tells it, with lipitor "we had a very clever regulatory crew who figured out that we could file for familial hypercholesterolemia, which is a very small group of patients in the United States. We used some South African data, because there it is a genetic thing. We included that data in the label, and we got approval in five months!" The same tack worked with Rezulin. Rather than simply applying as a me-too drug for treatment of type 2 diabetes, Parke-Davis emphasized that the drug was needed for people who wanted to take fewer insulin shots. |
| The new drugs: they could ensure that the company would not only survive, but dominate. Both lipitor and Rezulin targeted huge new growth markets, those with high cholesterol and those with type 2 diabetes. In many ways, both drugs were products of the newly loosened and speeded-up regulatory processes that the industry had been engineering since Hatch-Waxman. Both had benefited in their development from research and researchers from the NIH, who had been freed from old conflict-of-interest limits by the Engman-era Bayh-Dole Act. |
| Here was his proposal: If he could raise the sales of these drugs to 15 percent of their respective markets, he said, would Warner-Lambert guarantee that he, as head of Parke-Davis, could use those profits to promote lipitor and Rezulin when they were approved? A deal was struck.
Even before he landed in the United States, Wild was hammering away at creating a new Parke-Davis culture. The first problem was the gloom and doom, he said. That inhibited creativity. "The low-risk approach can end up as the high-risk approach," he explained in a later interview. |
| Reading over the lipitor label, then looking at studies of consumer awareness, he had a revelation: the campaign shouldn't even mention such bummers as heart attacks and cardiovascular disease, the reasons for the drug's existence. Instead the campaign should be ... fun. "We had a fairly good efficacy advantage, and a statin was by then well understood by doctors and patients," he recalls. "So we didn't feel that we had to discuss heart attacks. That would have been a confusing message.
"Instead, we took a consumer insight: people liked to compare their cholesterol numbers! |
Jack Challem See book keywords and concepts |
Statin Drugs Reduce CoQIO Levels
Fatigue, liver disease, and heart failure are among the risks associated with "statin" drugs, the largest category of cholesterol-lowering drugs (which include lipitor, Mevacor, Pravachol, Zocor, and the now banned Baycol). According to studies by Dr. Peter Langsjoen and many other researchers, statin drugs also decrease the body's production of CoQIO.
These drugs work by reducing the activity of a key enzyme involved in the production of cholesterol. However, the same enzyme is needed for CoQIO synthesis. |
Michael Friedman, ND See book keywords and concepts |
The main enzyme necessary for this reaction involves the HMG Co A reductase. lipitor and other drugs under the classification of statin drugs inhibit this pathway. Statin drugs are named after a compound synthesized
Hypercholesterolemia Causes
In treating high cholesterol levels, it is important to determine the cause. Causes of elevated serum cholesterol can be found in a variety of illnesses and conditions. |
Jacky Law See book keywords and concepts |
In contrast, the high-dose lipitor was designed to reduce levels to 70, substantially lower than the guidelines. The investigators followed patients for up to 2 years, and noted significant clinical events including overall mortality, heart attacks, unstable angina, the need for revascularization, and stroke incidence. And it did what the trial name suggested, proving among the vast majority of cardiologists that lower really is better. |
| Paxil (Seroxat) in the same way, and Pfizer has paid $49 million for not providing a best price for its bestselling statin, lipitor. Between 2000 and 2003, it was estimated that eight drug companies paid out a total of $2.2 billion in fines and settlements. Four - TAP Pharmaceuticals, Abbott, AstraZeneca and Bayer - pleaded guilty to criminal charges.10
Companies were also pulled up for marketing drugs for unapproved uses, for misleading advertising and for manufacturing irregularities. |
| This happens because the company finds it commercially advantageous to bundle its brand-leading lipitor up with the new drug in one combination pill. The new drug is not made available on its own; it only comes as part of a package deal.
As the company embarked on clinical trials for this, Dr Jerry Avorn said in the New England Journal of Medicine:
The current trial designs may not optimally meet the scientific needs of prescribers, the clinical needs of patients, the economic needs of payers, or the regulatory needs of policymakers. |
John A. McDougall See book keywords and concepts |
COX-2 inhibitors (like Celebrex and Vioxx)
Painkillers (Tylenol)
Cholesterol-lowering drugs (like Mevacor, Zocor, lipitor, and niacin)
Diabetic medications (Precose, Actos, Avandia, and sulfonylureas)
Estrogens
Anabolic steroids
Antibiotics
Antifungals
Anticonvulsants
Antidepressants
Antiarthritic (methotrexate)
Anti-acne (Accutane)
Vitamin A (retinol)
For a more complete listing of drugs that can cause liver damage, look through a Physicians' Desk Reference at your local library or bookstore. |
Michael T. Murray See book keywords and concepts |
While many physicians appear to be aware of the effect of lipitor and Pravachol on C-reactive protein, they do not seem to be aware that vitamin E (800 IU daily) lowered C-reactive protein by 49 percent and niacin (1,500 mg at night) lowered it by 20 percent.22'23
If You Use a Statin Drug, Take CoQIO
The statin drugs not only inhibit the manufacture of cholesterol, but also inhibit the making of coenzyme Q10 (CoQIO)—one of the most important nutrients for heart health. Its role in the heart is similar to the role of a spark plug in a car engine. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D. See book keywords and concepts |
Stephen Sinatra, MD, a cardiologist, is a leading proponent of CoQ10 supplementation, especially for patients on statin-type cholesterol-lowering drugs like Crestor, lipitor, and Zocor. These medications work by blocking an enzyme that is critical for the production of cholesterol. That same enzyme is essential for the manufacture of CoQ10.
According to Dr. Sinatra, patients with heart disease or congestive heart failure "must be given supplemental doses of coenzyme Q10 to offset the depleting effects of cholesterol-lowering agents. |
Peter Rost See book keywords and concepts |
Pfizer's products, which include Viagra and lipitor, sit on wholesalers' shelves for an average of 0.8 months."3 That is a ^difference.
So What Is The Problem?
Usually executives need to grow sales 5-10 percent in a fiscal year to earn a bonus. But let's assume they can't meet their own forecasts and they decide to sell more products to the wholesalers (who distribute to pharmacies) than the market can bear, to make it look as if sales increased. The wholesaler, however, can't sell all its inventory to the pharmacy, so wholesaler inventory increases. |
Joe Graedon, M.S. and Teresa Graedon, Ph.D. See book keywords and concepts |
This surprised his doctor, who assumed that he would require a prescription for lipitor (atorvastatin) or Zocor (simvastatin) sooner or later.
What impresses us is his persistence. He is always very careful about what he eats. We asked him how he manages to keep it up day after day, and he said he makes it like a game with himself. He actually shifts back and forth between a low-carb pattern and a low-fat pattern, which helps him prevent boredom. But on any given day, he decides which diet he is following and challenges himself to see how closely he can adhere to it. |
Jacky Law See book keywords and concepts |
Leading the table was Pfizer's lipitor which earned $10.3 billion, followed by another cholesterol-reducing drug, Merck's Zocor, which had sales of $6.1 billion. These statins, as they are called, are just two players in what was then a $26.1 billion class of drugs and had grown to $29.2 billion in the year to September 2004, according to global pharma data company, IMS Health.
These drugs have been shown to save lives by reducing cholesterol levels. To compete in such markets, companies need not only good candidate players (drugs), but also sufficient marketing spend. |